Patients sought for chronic pain study at Holy Cross

Holy Cross Hospital in Fort Lauderdale is one of only two Florida facilities participating in a national study on a cutting-edge device designed to ease chronic pain.

The medical center is looking for pain patients who fit certain criteria to participate in the trial, at no cost to them, in hopes of determining whether the Axium Neurostimulator System works better than standard spinal cord stimulators.

Like standard stimulators used to treat back pain, the Axium Neurostimulator is a small, implantable device that delivers electrical impulses to interrupt pain signals. The Axium, however, specifically targets the dorsal root ganglion, a special part of the spinal cord that regulates sensation, said Dr. William McRoberts, an interventional physiatrist leading the ACCURATE Clinical Study at Holy Cross.

"It's kind of like interrupting the pain signal specifically in the one spot where you have the entire attention of the pathway," McRoberts said. "That's why the hope is that it could be very good."

To qualify for participation, patients must be ages 22 to 75, have had chronic pain in their lower limbs for at least six months and not had lasting success from other treatments. Patients experiencing pelvic pain from a nerve injury would also be ideal, McRoberts said. In all, the trial hopes to have 152 patients participate across the country.

The trial, sponsored by the Axium's manufacturer, California-based Spinal Modulation Inc., began earlier this year and, if successful, could help the still-experimental device win approval from federal regulators. About 25 sites are participating across the country, with Holy Cross and a Merritt Island pain clinic the only Florida facilities involved, according to Spinal Modulation.

Patients will be randomly assigned to receive either the Axium or a standard spinal cord device. If they are happy with the preliminary results of the device's temporary placement, they can have it implanted permanently at no cost.

The study will follow patients for a year, then perform another two-year follow-up to determine the device's effectiveness, McRoberts said.

Kimberlee Schear, 41, a liberal arts professor at Lynn University in Boca Raton, is looking forward to seeing how the Axium performs. An active mom who has suffered from pain in her lower left leg since 2009, Schear said she has missed out on important activities and events in her life because the pain kept her from traveling much or walking long distances.

She found relief six months ago, when McRoberts implanted a standard spinal cord stimulator, which Schear controls with a small remote, allowing her to adjust the frequency and intensity of pain-interrupting electrical pulses. The procedure was a success.

"I have my life back," she said. "I hardly have pain, and when I do, I just turn up the device."

But the stimulator is not perfect, she said. Because it's not as targeted as the Axium, it delivers electrical signals to other parts of her leg that don't need it, leaving her with "annoying" vibrating sensations.

If the Axium eventually receives approval, Schear said she'd like to try it to see if it relieves the pain, without the extra vibrations.

For more information on the study, call 888-978-8397 or go to accuratestudy.com.